Recent legislation aimed at enhancing the attractiveness of the German pharmaceutical market includes provisions that allow pharmaceutical companies to request that the reimbursement amounts negotiated with health insurers remain confidential.
However, the proposal for confidential rebates has faced significant criticism over the past months, particularly from the National Association of Statutory Health Insurance Funds (GKV-SV). In response to these criticisms, amendments have been made prior to the approval of the Market and Supply of Pharmaceuticals Act (MFG) yesterday:
- Post-negotiation choice: A pharmaceutical company can only choose the option of confidential rebates after price negotiations have been finalized. Manufacturers will have five days to decide.
- Mandatory discount: Opting for confidential rebates will result in a mandatory 9% discount on the negotiated price.
- Doctor’s access: To ensure the most cost-effective drugs are prescribed, doctors will have access to information on confidential rebates.
- Research incentive: Only pharmaceutical companies conducting research in Germany are entitled to opt in.
- Temporary provision: The provision of confidential rebates is limited until June 30, 2028, with the possibility of an extension.
- Impact evaluation: The Ministry of Health will evaluate the impact of confidential rebates by the end of 2026.
While Germany is moving one step closer to reducing price transparency when other countries are aiming for more openness, the approved legislation may not be as favourable to manufacturers due to these recent amendments.
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Sources:
https://www.aerzteblatt.de/nachrichten/152642/Bundestag-verabschiedet-Medizinforschungsgesetz
https://www.pharmazeutische-zeitung.de/bundestag-beschliesst-medizinforschungsgesetz-148504